Recommended For:
• All surgeries, especially high risk procedures in orthopaedics, trauma, and cardiac.
• Damp donning.
• Easy identification of a glove breach.
• Use as an underglove when double gloving.
Further Information:
• Helps keep skin moist and supple.
• Effortless dry and damp donning as well as intra–operative changes.
• Additional cleaning processes to minimize the risk of developing allergies and sensitivities.
• Designed with DERMASHIELD Technology internal coating, together with the built–in moisturizer, facilitates dry and damp donning as well as intra–operative changes.
• These powder–free gloves are designed using Ansell's unique anatomic formers, ensuring greater comfort and an improved fit, for lesser hand fatigue during high–risk procedures.
Specification:
Material: Natural Rubber Latex
Thickness: Standard
Grip Level: Low
Shape: Anatomic with Straight Fingers
Cuff Style: Straight with SUREFIT™ Technology
External Glove Surface: Smooth with Micro–Textured Finish
Internal Glove Surface: Coated with HYDRASOFT™ Technology
Allergy Prevention: None
Double Gloving Recommendation: Underglove
Tested For Use With Chemotherapy Drugs: Yes, in accordance with ASTM D6978 (Not listed in the US FDA 510k)
Freedom from Holes (Inspection level I): 0.65 AQL
Primary Skin Irritation: Not considered a primary irritant as per FHSA Regulation guidelines 16 CFR 1500 / ISO 10993–10
Skin Sensitization: No evidence of delayed dermal contact sensitization as per ISO 10993–10
Product Standards: AS/NZS 4179, EN 16523–1, EN 455 1–4, EN ISO 21420:2020, EN ISO 374–1:2016, EN ISO 374– 5:2016
Quality / Environmental Standards: EN 556, ISO 11137–Part 1, ISO 13485, ISO 14001, ISO 9001, Korean GMP
Product Certification: EU: CE Marked to MDD 93/42/EEC (Class IIa), PPE Regulation (EU) 2016/425 (Cat. III risks) AU: TGA # 201049
Storage Instructions: Keep out of direct sunlight; store in a cool and dry place. Keep away from sources of ozone or ignition.
Sterilization Method: GAMMA irradiation (25 kGy)
Viral Penetration: Passes ASTM F1671 using Phi X 174, Passes ISO 16604 using Phi X 174
Vulcanization Chemical Accelerators: Xanthogen Polysulphides, Sodium di–nbutyldithiocarbamate (SDBC), Zinc Diethyldithiocarbamate (ZDEC)